The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.

Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.

The Management of Diabetes in Everyday Life (MODEL) program: development of a tailored text message intervention to improve diabetes self-care activities among underserved African-American adults.

Tailoring health-related materials is an effective mechanism to encourage behavior change; however, little research has described processes and critical characteristics for effective tailoring in underserved populations. The purpose of this study is to describe a process using input from content experts and lay patient advisors to tailor text messages focused on improving self-care behaviors of African-American adults with diabetes and identify characteristics of messages perceived to be most effective. An initial library of tailorable messages was created using theory-based approaches, expert opinion, and publicly available materials. A study-specific advisory council representing the program's intended population provided sequential individual and focus group review of a sample of draft messages focused on medication use, healthy eating, and physical activity. Messages were reviewed for content, tone, and applicability to African-American adults with diabetes from underserved communities. Based on this feedback, messages were revised and a final library of tailorable messages was constructed for use in a text messaging intervention. The initial library had over 5,000 tailorable messages. Participants preferred messages that included: (1) encouraging statements without condescension; (2) short sentences in lay language; (3) specific, actionable instructions; and (4) content relatable to daily activities of living. When possible, messages with similar themes should be repeated over short periods of time to improve the odds of material being absorbed and action being taken. Input from patient participants and advisors is essential for designing deeply tailored messages that honor the preferences, values, and norms of the population under study and promote health behavior change. TRIAL REGISTRATION: NCT02957513.

The impact of work-related stress on medication errors in Eastern Region Saudi Arabia.

OBJECTIVE: To examine the relationship between overall level and source-specific work-related stressors on medication errors rate. DESIGN: A cross-sectional study examined the relationship between overall levels of stress, 25 source-specific work-related stressors and medication error rate based on documented incident reports in Saudi Arabia (SA) hospital, using secondary databases. SETTING: King Abdulaziz Hospital in Al-Ahsa, Eastern Region, SA. PARTICIPANTS: Two hundred and sixty-nine healthcare professionals (HCPs). MAIN OUTCOME MEASURES: The odds ratio (OR) and corresponding 95% confidence interval (CI) for HCPs documented incident report medication errors and self-reported sources of Job Stress Survey. RESULTS: Multiple logistic regression analysis identified source-specific work-related stress as significantly associated with HCPs who made at least one medication error per month (P < 0.05), including disruption to home life, pressure to meet deadlines, difficulties with colleagues, excessive workload, income over 10 000 riyals and compulsory night/weekend call duties either some or all of the time. Although not statistically significant, HCPs who reported overall stress were two times more likely to make at least one medication error per month than non-stressed HCPs (OR: 1.95, P = 0.081). CONCLUSION: This is the first study to use documented incident reports for medication errors rather than self-report to evaluate the level of stress-related medication errors in SA HCPs. Job demands, such as social stressors (home life disruption, difficulties with colleagues), time pressures, structural determinants (compulsory night/weekend call duties) and higher income, were significantly associated with medication errors whereas overall stress revealed a 2-fold higher trend.

Unmet Primary Care Needs in Diabetic Patients with Multimorbidity in a Medically Underserved Area.

BACKGROUND: Diabetic patients with multimorbidity in medically underserved minority communities are less engaged in primary care and experience high emergency department (ED) utilization. This study assesses unmet primary care needs among diabetic patients in a medically underserved area (MUA). COMMUNITY CONTEXT: A suburb of Memphis-Whitehaven, Tennessee (Shelby County, ZIP codes 38109 and 38116)-majority African American (96.6%) with 30.5% below the poverty level. METHODS: Community case study using multiple data sources including diabetes registry, individual interviews, focus groups, and a survey of 30 ED patients with diabetes and multimorbidity. RESULTS: Diabetes registry data indicated that 95.5% of 5723 diabetic patients had multimorbidity. Over 91.5% were uncontrolled at some point in 2014 to 2015. Only 83% of patients with diabetes and multimorbidity reported having a primary care provider (PCP) and those without a PCP were more likely to report delays in needed care. Patients expressed strong interest in health coaching (88%) and receiving text messages from the doctor's office (73%). Individual patient interviews (n = 9) and focus groups (n = 11) revealed common primary care and self-care experiences and needs including diabetes education, improved patient-provider communication, health-care access and coverage, and strengthened primary care and community. CONCLUSION: This study demonstrates that almost 1 in 5 ED complex diabetic patients in an MUA do not have a PCP, and that difficulty accessing primary care often results in patients forgoing needed care. Qualitative findings support these conclusions. These results suggest that primary care capacity and infrastructure to support diabetes self-care need strengthening in MUAs.

Development and psychometric testing of a multidimensional instrument of perceived discrimination among African Americans in the Jackson Heart Study.

OBJECTIVE: Assessing the discrimination-health disparities hypothesis requires psychometrically sound, multidimensional measures of discrimination. Among the available discrimination measures, few are multidimensional and none have adequate psychometric testing in a large, African American sample. We report the development and psychometric testing of the multidimensional Jackson Heart Study Discrimination (JHSDIS) Instrument. METHODS: A multidimensional measure assessing the occurrence, frequency, attribution, and coping responses to perceived everyday and lifetime discrimination; lifetime burden of discrimination; and effect of skin color was developed and tested in the 5302-member cohort of the Jackson Heart Study. Internal consistency was calculated by using Cronbach alpha coefficient. Confirmatory factor analysis established the dimensions, and intercorrelation coefficients assessed the discriminant validity of the instrument. SETTING: Tri-county area of the Jackson, MS metropolitan statistical area. RESULTS: The JHSDIS was psychometrically sound (overall alpha = .78, .84 and .77, respectively, for the everyday and lifetime subscales). Confirmatory factor analysis yielded 11 factors, which confirmed the a priori dimensions represented. CONCLUSIONS: The JHSDIS combined three scales into a single multidimensional instrument with good psychometric properties in a large sample of African Americans. This analysis lays the foundation for using this instrument in research that will examine the association between perceived discrimination and CVD among African Americans.